Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Ki67 (K2) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Ki67 nuclear antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0230
In Commercial Distribution

  • 05055331318053 ()
PA0230

  • Ki67 antigen IVD, antibody
Beta-Catenin (17C2) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human beta-catenin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0083
In Commercial Distribution

  • 05055331318039 ()
PA0083

  • Beta-catenin IVD, antibody
Cytokeratin 17 (E3) monoclonal antibody is intended to be used for the qualitative identification by light microscopy human cytokeratin 17 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0114
In Commercial Distribution

  • 05055331318022 ()
PA0114

  • Cytokeratin IVD, antibody
Multiple Myeloma Oncogene 1 (MUM1) (EAU32) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human multiple myeloma oncogene 1 (MUM1) in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0129
In Commercial Distribution

  • 05055331318015 ()
PA0129

  • MUM1 transcription factor IVD, antibody
Tartrate-Resistant Acid Phosphatase (26E5) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human tartrate-resistant acid phosphatase in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0093
In Commercial Distribution

  • 05055331318008 ()
PA0093

  • Tartrate resistant acid phosphatase (TRAP) IVD, antibody
Galectin-3 (9C4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human galectin-3 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0238
In Commercial Distribution

  • 05055331317902 ()
PA0238

  • Galectin-3 IVD, antibody
Gastrin (Polyclonal) antibody is intended to be used for the qualitative identification by light microscopy of human gastrin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0681
In Commercial Distribution

  • 05055331317858 ()
PA0681

  • Gastrin IVD, antibody
NCL-L-MUM1 is intended for the qualitative identification by light microscopy of human multiple myeloma oncogene 1 (MUM-1) in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
MUM1-L-CE
In Commercial Distribution

  • 05055331317773 ()
NCL-L-MUM1

  • MUM1 transcription factor IVD, antibody
NCL-L-IgG is intended for the qualitative identification by light microscopy of human immunoglobulin G (IgG) molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
IGG-L-CE
In Commercial Distribution

  • 05055331317711 ()
NCL-L-IgG

  • Total immunoglobulin G (IgG total) IVD, antibody
NCL-L-AMACR is intended for the qualitative identification by light microscopy of alpha-methylacyl-CoA racemase (AMACR) molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
AMACR-L-CE
In Commercial Distribution

  • 05055331317414 ()
NCL-L-AMACR

  • p504s protein IVD, antibody
NCL-L-5D3 is intended for the qualitative identification by light microscopy of Cytokeratin (8/18) molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
5D3-L-CE
In Commercial Distribution

  • 05055331317193 ()
NCL-L-5D3

  • Cytokeratin IVD, antibody
NCL-L-a-SARC is intended for the qualitative identification by light microscopy of Alpha-Sarcoglycan (Adhalin) by immunohistochemistry.
LEICA BIOSYSTEMS NEWCASTLE LTD
A-SARC-L-CE
Not in Commercial Distribution

  • 05055331317100 ()
NCL-L-a-SARC

  • Sarcoglycan complex IVD, antibody
NCL-L-AE1/AE3 is intended for the qualitative identification by light microscopy of cytokeratin molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
AE1/AE3-L-CE
Not in Commercial Distribution

  • 05055331316967 ()
NCL-L-AE1/AE3

  • Cytokeratin IVD, antibody
NCL-L-Akt-Phos is intended for the qualitative identification by light microscopy of Akt (Phosphorylated) molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
AKT-PHOS-L-CE
Not in Commercial Distribution

  • 05055331316875 ()
NCL-L-AKT-PHOS

  • Protein kinase B IVD, antibody
NCL-b-DG is intended for the qualitative identification by light microscopy of Beta-Dystroglycan by immunohistochemistry.
LEICA BIOSYSTEMS NEWCASTLE LTD
B-DG-CE
Not in Commercial Distribution

  • 05055331316424 ()
NCL-b-DG

  • Beta-dystroglycan IVD, antibody
NCL-L-b-SARC is intended for the qualitative identification by light microscopy of Beta-Sarcoglycan by immunohistochemistry.
LEICA BIOSYSTEMS NEWCASTLE LTD
B-SARC-L-CE
Not in Commercial Distribution

  • 05055331316356 ()
NCL-L-b-SARC

  • Sarcoglycan complex IVD, antibody
NCL-L-bcl-2 is intended for the qualitative identification by light microscopy of human bcl-2 oncoprotein in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
BCL-2-L-CE
In Commercial Distribution

  • 05055331316226 ()
NCL-L-bcl-2

  • Bcl-2 oncoprotein IVD, antibody
NCL-L-Bcl-6-564 is intended for the qualitative identification by light microscopy of human Bcl-6 oncoprotein in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
BCL-6-564-L-CE
In Commercial Distribution

  • 05055331316141 ()
NCL-L-Bcl-6-564

  • Bcl-6 protein IVD, antibody
NCL-L-CA125 is intended for the qualitative identification by light microscopy of CA125 (Ovarian Cancer Antigen) molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CA125-L-CE
In Commercial Distribution

  • 05055331315816 ()
NCL-L-CA125

  • Cancer antigen 125 (CA125) IVD, antibody
NCL-L-CAIX is intended for the qualitative identification by light microscopy of Carbonic Anhydrase IX molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CAIX-L-CE
In Commercial Distribution

  • 05055331315762 ()
NCL-L-CAIX

  • Carbonic anhydrase IVD, antibody
NCL-L-CALRET-566 is intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CALRET566-L-CE
In Commercial Distribution

  • 05055331315571 ()
NCL-L-CALRET-566

  • Calretinin protein IVD, antibody
NCL-L-CB11 is intended for the qualitative identification by light microscopy of c-erbB-2 Oncoprotein molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CB11-L-CE
In Commercial Distribution

  • 05055331315304 ()
NCL-L-CB11

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody
NCL-L-CBE-356 is intended for the qualitative identification by light microscopy of c-erbB-2 Oncoprotein molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CBE-356-L-CE
In Commercial Distribution

  • 05055331315229 ()
NCL-L-CBE-356

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody
NCL-L-CD10-270 is intended for the qualitative identification by light microscopy of human CD10 molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD10-270-L-CE
In Commercial Distribution

  • 05055331315106 ()
NCL-L-CD10-270

  • CD10 cell marker IVD, antibody
NCL-L-CD117 is intended for the qualitative identification by light microscopy of c-kit Oncoprotein (CD117) molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD117-L-CE
In Commercial Distribution

  • 05055331314963 ()
NCL-L-CD117

  • CD117 (c-kit) cell marker IVD, antibody
NCL-L-CD11c-563 is intended for the qualitative identification by light microscopy of human CD11c antigen in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD11C-563-L-CE
In Commercial Distribution

  • 05055331314901 ()
NCL-L-CD11c-563

  • CD11c cell marker IVD, antibody
RTU-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections
LEICA BIOSYSTEMS NEWCASTLE LTD
CD15-R-7-CE
In Commercial Distribution

  • 05055331314635 ()
RTU-CD15

  • CD15 cell marker IVD, antibody
NCL-L-CD19-163 is intended for the qualitative identification by light microscopy of human CD19 in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD19-163-L-CE
In Commercial Distribution

  • 05055331314475 ()
NCL-L-CD19-163

  • CD19 cell marker IVD, antibody
NCL-L-CD1a-235 is intended for the qualitative identification by light microscopy of human CD1a molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD1A-235-L-CE
In Commercial Distribution

  • 05055331314352 ()
NCL-L-CD1a-235

  • CD1a cell marker IVD, antibody
NCL-L-CD2-271 is intended for the qualitative identification by light microscopy of CD2 (LFA-2) molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD2-271-L-CE
In Commercial Distribution

  • 05055331314277 ()
NCL-L-CD2-271

  • CD2 T-cell marker IVD, antibody
NCL-L-CD20-L26 is intended for the qualitative identification by light microscopy of CD20 molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD20-L26-L-CE
In Commercial Distribution

  • 05055331314178 ()
NCL-L-CD20-L26

  • CD20 cell marker IVD, antibody
NCL-L-CD21-2G9 is intended for the qualitative identification by light microscopy of CD21 molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD21-2G9-L-CE
In Commercial Distribution

  • 05055331314086 ()
NCL-L-CD21-2G9

  • CD21 cell marker IVD, antibody
NCL-L-CD23-1B12 is intended for the qualitative identification by light microscopy of human CD23 molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD23-1B12-L-CE
In Commercial Distribution

  • 05055331314000 ()
NCL-L-CD23-1B12

  • CD23 cell marker IVD, antibody
NCL-L-CD3-565 is intended for the qualitative identification by light microscopy of human CD3 antigen in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD3-565-L-CE
In Commercial Distribution

  • 05055331313850 ()
NCL-L-CD3-565

  • CD3 cell marker IVD, antibody
NCL-L-CD30-591 is intended for the qualitative identification by light microscopy of CD30 protein in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD30-591-L-CE
In Commercial Distribution

  • 05055331313690 ()
NCL-L-CD30-591

  • Tumour necrosis factor receptor superfamily IVD, antibody
NCL-L-CD33 is intended for the qualitative identification by light microscopy of human CD33 in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD33-L-CE
In Commercial Distribution

  • 05055331313546 ()
NCL-L-CD33

  • CD33 cell marker IVD, antibody
NCL-L-CD38-290 is intended for the qualitative identification by light microscopy of CD38 molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD38-290-L-CE
In Commercial Distribution

  • 05055331313430 ()
NCL-L-CD38-290

  • CD38 cell marker IVD, antibody
NCL-L-CD5-4C7 is intended for the qualitative identification by light microscopy of human CD5 molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD5-4C7-L-CE
In Commercial Distribution

  • 05055331313072 ()
NCL-L-CD5-4C7

  • CD5 cell marker IVD, antibody
NCL-L-CD7-580 is intended for the qualitative identification by light microscopy of human CD7 antigen in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD7-580-L-CE
In Commercial Distribution

  • 05055331312631 ()
NCL-L-CD7-580

  • CD7 cell marker IVD, antibody
NCL-L-CD79a-225 is intended for the qualitative identification by light microscopy of CD79a molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CD79A-225-L-CE
Not in Commercial Distribution

  • 05055331312488 ()
NCL-L-CD79a-225

  • CD79a cell marker IVD, antibody
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